Cue Biopharma initiates patient dosing in Phase 1 study of CUE-101
Cue Biopharma announced today that on September 23, 2019 it dosed the first patient in a Phase 1 clinical trial of CUE-101 at Washington University, Alvin J. Siteman Cancer Center, St. Louis, Missouri for the treatment of HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma. Enabled by the company's proprietary Immuno-STAT platform, CUE-101 is the company's lead biologic drug candidate from the IL-2 based CUE-100 series, designed to directly engage and activate T cells in the body to target HPV-driven cancers. The trial is a multi-center, open-label, Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 as a monotherapy in patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A*02:01 serotype. The study is designed to enroll approximately 50 patients. Based on translational analysis/data from the trial, the company may expand the study to test CUE-101 both as a neoadjuvant therapy and potentially in combination with checkpoint inhibitors in patients with HPV16-driven recurrent/metastatic HNSCC.